| Date/Time: |
Monday, November 22, 2010, 8:15 AM |
| Keynote Address: |
“Biomarkers as Mediators of Clinical Trial Results: The Women’s Health Initiative Clinical Trial” |
| Speaker: |
Ross Prentice, Ph.D., Director, Public Health Sciences Division, Fred Hutchinson Cancer Research Center and Professor of Biostatistics, University of Washington |
| |
| Date/Time: |
Monday, November 22, 2010, 1:45 PM |
| Keynote Address: |
“Recent Developments in the Use of Clinical Trials to Support Individualizing Therapies: A Regulatory Perspective” |
| Speaker: |
Robert O’Neill, Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health & Human Services |
| |
| Date/Time: |
Tuesday, November 23, 2010, 8:15 AM |
| Keynote Address: |
“Past, Present and Future of Product Safety Assessments” |
| Speaker: |
Robert Temple, M.D., Director (Acting), Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration |
